OCS Liver DCD Trial

January 9, 2024 updated by: TransMedics

Prospective Trial to Evaluate the Effectiveness of The Portable Organ Care System (OCS) Liver for Preserving, Optimizing and Assessing Currently Seldom Utilized DCD Donor Livers for Transplantation

Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • La Jolla, California, United States, 92037
        • Scripps
      • La Jolla, California, United States, 92037
        • University of San Diego
      • San Francisco, California, United States, 94143
        • UCSF
      • Stanford, California, United States, 94305
        • Stanford University
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwest
      • Houston, Texas, United States, 77030
        • Houston Methodist
      • San Antonio, Texas, United States, 78249
        • University of Texas San Antonio
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Registered primary liver transplant candidate
  • Age ≥ 18 years
  • Obtained informed consent

Exclusion Criteria:

  • Acute, fulminant liver failure
  • Prior solid organ or bone marrow transplant
  • Ventilator dependent on day of transplant/donor organ offer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCS Preserved Livers
This is a single-arm trial of OCS preserved livers used for transplantation.
The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver graft survival through 6 months post-transplant
Time Frame: 6 months
Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of donor liver utilization after OCS liver perfusion
Time Frame: OCS liver perfusion
The number of eligible donor livers that were instrumented and perfused on OCS liver system and successfully transplanted, divided by the number of eligible donor livers that were instrumented and perfused on OCS
OCS liver perfusion
Incidence of ischemic biliary cholangiopathy at 6 months post-transplant
Time Frame: 6 months
Evaluation of ischemic biliary complications
6 months
Incidence of Early Allograft Dysfunction (EAD) or primary non-function
Time Frame: 7 days
Evaluation of EAD via AST, Bilirubin and INR
7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and graft survival
Time Frame: Day 30
Survival as determined by follow-up visit/call with patient or health care provider.
Day 30
Patient and graft survival
Time Frame: 6 months
Survival as determined by follow-up visit/call with patient or health care provider.
6 months
Patient and graft survival
Time Frame: 12 months
Survival as determined by follow-up visit/call with patient or health care provider.
12 months
Patient and graft survival
Time Frame: 24 months
Survival as determined by follow-up visit/call with patient or health care provider.
24 months
Patient and graft survival
Time Frame: 36 months
Survival as determined by follow-up visit/call with patient or health care provider.
36 months
Patient and graft survival
Time Frame: 48 months
Survival as determined by follow-up visit/call with patient or health care provider.
48 months
Patient and graft survival
Time Frame: 60 months
Survival as determined by follow-up visit/call with patient or health care provider.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Ahmed Elbetanony, MD, TransMedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2020

Primary Completion (Actual)

March 22, 2022

Study Completion (Estimated)

November 19, 2026

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • OCS-LVR-092019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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